CA3016065A1

CA3016065A1 - Devices and methods for managing chest drainage

Info

Publication number: CA3016065A1
Application number: CA3016065A
Authority: CA
Inventors: Evan S. LUXON; Daniel R. Burnett; Randy PRESTON; Ryan COUGHLIN; Mark Ziegler; Derek WALLIN
Original assignee: Esculon LLC
Current assignee: Esculon LLC
Priority date: 2016-03-03
Filing date: 2017-03-03
Publication date: 2017-09-08
Also published as: AU2017228404B2; US20180104391A1; EP4000678A1; EP3407956A2; WO2017152125A2; WO2017152125A3; US10265442B2; JP2022081647A; AU2023201572A1; JP2019507642A; EP3407956A4; AU2021215257A1; JP2021118897A; AU2017228404A1; US20190201596A1; EP3407956B1; JP7044926B2

Abstract

Disclosed is a chest drainage system which reduces or eliminates pooling of blood/liquid and/or clogging/clotting in the drainage tube and/or chest tube, and provides objective and accurate measures of drained fluid volume and chest air leak. The chest drainage system continuously monitors chest tube and drainage tube status and clears pooled liquid in the drainage tube, and/or a clogged chest tube when necessary to restore negative pressure to the chest.

Description

DEVICES AND METHODS FOR MANAGING CHEST DRAINAGE
CROSS-REFERENCE TO RELATED APPLICATION'S
r.0001.1 This application claims the benefit of priority to U.S. Provisional Application No.
62/303,361 filed. March 3'1, 2016 and U.S. Provisional Application No.
62328,560 filed .April 27th, 2016 and U.S. Provisional Application No. 62/365,770 filed July 22'1, 2016 and Provisional Application No. 621448,546 filed January 20, 201.7, each of which is incorporated herein by reference in its entirety, FIELD OF THE INVENTION
100021 The present invention relates to wound and surgical. drainage INCORPORATION 3Y .R.EFFAENcf.:
100031 All publicatiOns and patent applications. Mentioned in this VeCification are herein 1.5 incorporated b);,, reference to the same extent as if each such individual publication or patent application were specifically and indi-vid.u.ally indicated to be so incorporated by reference.
BACKGROUND OF THE INVENTION
100041 Chest tubes are required any time air audiouliquid accumulatcs in the .c.licst cavity,.
disruptine normal ptihnonary or cardiac function. Suction is applied continuously to remove excess air and/or fluid from the chest until the Mternal wounds have healed, at which point the chest tubes can be removed. One of the most common uses of chest tubes is to drain the area around the heart after cardiac surgery.
1000.51 Despite their benefits, current chest tube systems suffer from two major flaws. First, as liquid drains from the chcst toward the suction container, it. can pool M
the drainage tubing and prevent the applied negative pressure from beiNõ, transmitted to the chest. When this occurs, the pressure in the chest can bc reduced to zero or even become positive. Second, clogs can form that obstruct the chest tube, which prevent the negative pressure from being transmitted to the chest and inhibit drainage. In facts 36% of cardiac surgery patients experience chest tube clogging. When proper drainage is inhibited due to these factors, patients are at increased risk for accumulation of fluid around the heart, known as pericardial tamponade, which resuhs in shock and can be fatal. Additionally, the lungs may be compressed, which can lead to respiratory compromise and can be fatal as well.
100061 Pooling of liquid in the drainage the can theoretically be remedied .by keeping the tubing straight from the patient to the c.ollection container. However, this is nearly impossible in practice, as some slack is required to prevent accidental dislodging of the tube from the body. To combat clogging, clinicians use two methods known. as .milking and stripping_ Milking refers to line manipulations such as lifting, squeezing, or kneading.
Stripping refers to a pulling along the length of the tube with the thumb and forefinger to increase the amount of suction at the end of the tube. However, these methods have not been Shown to be .10 effective at improving chest tube suction or drainage. In fact, stripping has actually been discouraged because it is possible to create extremely high negative pressures (up to -370 cmIi20) that niay damage the tissue.
109071 .In addition to these functional flaws, current systems &so rely on .measures of collected fluid volume and rate of chest air leak, which are subjective and lead to imprecision and inaccuracies in the measurements. As a result, clinicians make cautious clinical decisions based. on these measurements, keeping patients in the hospital longer than necessary, SUMMARY OF THE INVENTION
f0008i A chest drainage system is needed which reduces or eliminates pooling of bloodiliquid andior clogging/clotting in the drainage tube andfor chest tube, and provides objective and accurate measures of collected fluid volume and chest/thoracic air leak, [00091 in one variation, the drainage system may generally comprise a tube configured for insertion into a body of a subiect, wherein .the tube defines a tube relief lumen and tube drainage lumen in fluid. communication with one .another; and a tube relief lumen valve in fluid communication with the tube relief 11.1111011 such that a pressure differential is formed.
between an ambient pressure and the tube relief lumen, wherein the tube relief lumen valve is configured to close at a first pressure differential and to open at a second .pressure differential which is different from the first pressure differential.
10010.1 in on exemplary method of maintaining the drainage system, the method.
may generally comprise pmvidinu a tube having a tube relief lumen and tube drainage lumen in fluid communication with one another and configured for insertion into a body of a subject, and a tube relief lumen valve in fluid communication with the tube .relief Itimen; and configuring the tube relief lumen valve from a closed configuration into an open

2 configuration, where the closed configuration is formed when a first pressure differential between an ambient pressure and the tube relief lumen is created_ and where the open configuration is fOrtned when a second pressure differential between the .ambient pressure and the tube relief lumen is created, wherein the .first pressure differential is .different from the second pressure differential.
1001.1.1 In another variation of the drainage system, the system may generally comprise a. tube configured for insertion into a body of a subject, wherein the tube defines a tube relief lumen and tube drainage lumen in fluid communication with one another; a tube relief lumen valve in fluid communication with the tube relief lumen; a suction pump in fluid.
communication .10 with the tube drainage lumen; and a (Zan:011er in communication with the tube, wherein the controller is programmed to actuate the suction pump at a first level of suction which maintains the tube relief lumen valve in a closed configuration and at a second level a suction "which reconfigures the tube relief hIMCII valve to an open configuration BRIEF DESCRIPTION OF THE DRAWINGS
100121 Fig. 1 shows an embodiment of the chest drainage system that does not include a relief lumen, [00131 Fig 2 shows another embodiment of the chest drainage system with active valves in the tube-tube interface area.
[00141 Fig. 3 shows an embodiment of the chest drainage system with an active drainage tube relief valve and a passive chest tube -relief valve 100151 Fig 4 shows an embodiment of the chest tube shown in Fig. 3 10016.1 Fig. 5 shows a magnetic. embodiment of the chest tube valve, [01.7.1 Fig. 6A shows the chest drainage system's ability to detect and clear pooled liquid in the drainage tube.
f00 18.I Figs, 6B-6F show the chest drainage system's ability to deteet and clear pooled liquid in the chest tube.
t00191 FIG. 7 is a block diagram of a data processing system, 100201 F. 8 shows a balloon with a compliant layer and a non-compliant layer.
.. 100211 Fig. 9 shows a tapered balloon.
100221 Fig. 10 shows an .accordion shaped balloon.

3 100231 Figs. 11A and 11B show chest tubes with incorporated balloons.
100241 Fig. 12 Shows an embodiment with a balloon -valve including energy delivery.
100251 Fig. 1.3 shows an embodiment Which include a magnetic wire.
100261 Figs. 14A-14C show an embodiment of a chest tube.
14)0271 Figs, I5A-15D show an embodiment of a valve device.
100281 Fitts. 16A-168 show an embodiment of a chest tube with a flush port.
100291 Figs. 17A-I 7D show an embodiment of a valve device.
100301 Figs. 18A. and 1813 show a method of measuring a chest/thoracic air leak using the chest drainage system.
100311 Fig 19 show a method of measuring a chestithoraeic air :leak psit* the Orainag0 system.
100321 Fig. 20 illustrates an embodiment of the chest tube.
100331 Fig, 21 shows an embodiment of the valve device 100341 Fig. 22 shows an embodiment of the valve device with the chest tube and drainage tube, 100351 Fig. 23 shows at embodiment of the chest drainage system in use.
it.10361 Fig. 24 shows the connection between the pneumatic connecters coming from the valve device and the monitor, 100371 Fig. 25 shows the connection between the pneumatic connecter and the monitor.
100381 Fig. 26 shows an embodiment of the chest drainage system.
100391 Figs. 27A-27D show an embodiment of the valve device.
100401 Figs. 28A-28C show a method of measuring chest/thoracic air leak.
100411 Fig. 29 depicts pressure over time for two different low flow air leak rate measurements.
100421 Fig: 30 shows a conversion of rate of pressure change to air leak.
100431 Fig. 31 depicts pressure over time for two different high flow air leak rate measurements.
100441 Fig. 32 Shows a conversion of rate of pressure change to air leak.
100451 Fig. 33 shows the relationship between color and reflectance readings.
100461 Fig, 34 shows the relation betweem surface angle and reflectance readings,

4

5 100471 Fig. 35 shows a display of elm-L//thoracic air leak information.
100481 Fig. 36 Shows a display of chestilthoracie air leak information.
100491 Fig. 37 shows a display of chest//thoracic air leak information.
00501 Fig, 38 shows a display of chest//thoracic air leak infOrmation, 100511 Fig. 39 shows a display of clog removal information.
100521 Fig. 40 shows a display of clog removal in formation.
100531 Fig 41 shows a display of suction pressure information.
100541 Fig. 42 shows a display of clog removal information, 10055! Figs. 43A-43E show manufacturing steps and components of balloon valves, 100561 Fig, 44 shows =embodiment of a mounting device.
t00571 Fig. 45 Shows an embodiment of a mounting device.
100581 Fig. 46 Shows an embodiment of a mounting device.
100591 Figs. 47-50 show an embodiment of a dual-lumen chest tube.
00601 Fig. 51 shows an embodiment of a dual-lumen Chest tube.
100611 Figs. 52A-52B show connection states between the pneumatic connecter and the monitor, 100621 Fig. 53 shows a manifold design.
100631 Fig. 54 shows a sliding mechanism.
100641 Fig, 55 shows an alternative configuration to the system depicted in Fig. 24.
100651 Fig. 56 Shows a spring activated valve.
10066! Fig. 57 shows an embodiment of a valve device..
10067! Fig. 58 shows a monitor/controller, 100681 Fig. 59 shows an embodiment of a collection:roervOirkanisW
100691 Fig. 60 shows a latching mechanism between the smnsttriromoir and the monitor.
100701 Fig. 61 shows a modular attachment receptacle.
100711 Fig. 62 shows an embodiment of a connection barb.
100721 Fig. 63 Shows a display.
00731 Fig. 64 shows a display, DETAILED DESCRIPTION OF THE INVENTION
100741 Disclosed is a chest drainage system which reduces or eliminates pooling of blood/liquid and/or clogging/clotting in the drainage tube and/or chest tube, and provides objective and accurate measures of drained fluid volume and chest air leak.
100751 The chest drainage system continuously monitors chest tube and drainage tube status and clears pooled liquid in the drainage tube, and/or a clogged chest tube when necessary to restore negative pressure to the chest. The system may include active and/or passive valve fiinctions, as well as a controller (also referred to herein as a .monitor) lig monitoring the .pressures in the system. The controller may control a pump for assisting in clearance of pooled liquid and/or clots in the drainage tube and/or chest tube. The controller may also control any active valves and/or suction device in response to measured pressure signals. The chest drainage system performs four primary functions:
100761 1. The chest drainage system detects pooled liquid in the drainage tube by monitoring the pressure at or near the chest tube-drainage tube interface (the tube-tube interface area).
Pooled liquid in the drainage tube is indicated by a decrease in vacuum (increasing pressure).
The chest drainage system may measure pressure with a sensor incorporated into the controller, The sensor may be in fluid communication with the tube-tube interface area via a fluid filled lumen (the relief lumen). The relief lumen may be open to atmosphere on the other end, and be filled with air, A valve (drainage tube valve or drainage tube relief lumen valve) may be used to open and dose the relief lumen, and may include a vent which prevents the transmission of bacteria and viruses from the atmosphere into the relief lumen.
The drainage tube valve may be opened and closed by the controller based on the measured pressure at the tube-tube interface area.
100771 Alternatively, the pressure sensor may be placed at the tubc.ohe interface. area,:
connected directly to atmosphere. in this embodiment, the pressure sensor is in communication with the controller and no relief lumen is present.
Alternatively, the drainage tube valve may be passive, either with or without a relief lumen.
I0078j 2, When pooled liquid is detected, the Chest drainage system clears the drainage tube by opening the drainage tube relief lumen valve which is in fluid communication with the tube-tube .interface area. Opening the drainage tube relief lumen valve allows air to sweep away the liquid in the drainage tube into the drainage container/reservoir. A
pump which may be integrated with the controller, applies negative pressure to the drainage tube (via a collection reservoir/cassette/chamber). Optionally the pump may also apply positive pressure

6 .the .relicf lumen (rather than its being open to atmospheric pressure) to help dear the blockage. Proper =negative pressure at the chest is then restored.
.Optionally, the system may apply negative pressure (or an increased negative pressure) to the drainage tube without opening the relief lumen valve. This serves as a temporary measure to restore proper suction and may or may not dear a blockage. This measure may be performed when the controller senses a blockage in the drainage tube, or may be performed at limited temporal intervals, 100791 3. Clots or dogs may form in the chest tube. To clear them, the suction magnitude applied at the tube-tube interface may be increased by the controller. A
passive valve, in fluid communieation with a chest tube relief lumen, may be configund to open when the .pressure .10 i.n the tube-Mbe interface drops below a set level This valve (chest tube rd el' valve) may be open to atmospheric pressure and include a .filter or -vent to prevent bacteria etc. from entering the system. Once the chest tube relief valve is open, the chest tube will be cleared. The chest tube relief valve may be configured to close at a pressure differential which is less than that of the opening pressure, to ensure the valve stays open long enough .for the chest tube to be cleared and to minimize the flow resistance of the Valve. Alternatively, the chest tube relief valve, may be an aciive valve, which opens and closes based on pressures measured in the tube-tube interface area andlor in the chest tube relief lumen. An active chest tube relief valve may open and dose at the same pressure differential or open and dose at different pressure differentials.
it.10801, In some embodiments, one or more of the valves are passive and set to open at a set pressure and stay open until the same, or another, set prssur is reached. In some embodiments, one or more of the valves are active. in either case, one or more valves may be set to open at one pressure, and close at another pressure.
10081.1 Fig. 1 Shows an embodiment of the chest drainage system that does not include a .relief lumen. :Patient chest 102 is drained using the chest drainage system.
Chest tube 104 is in direct fluid communication with the chest cavity. Drainage tube 1.06 is in fluid communication with collection chamber 116 which may be connected to suction device/controller 108. Valve device 110 which includes vent/valve 112 is between chest tube 104 and drainage tube 106. Alternatively, vent/valve 11.2 may be incorporated into the chest tube and/or drainage tube. Valve device 110 is ni fitnd. commmtication with both chest tube 104 and drainage tube 106. Valve device 110 may be controlled by a controller or may be controlled manually (this controller lilay be the same as, or different than, controller 108).
'The valve device may be used to periodically close off fluid flow from the chest tube and/or

7 open vent/valve 112 to allow air to enter the drainage tube and dear my obstructions or restrictions hi the drainage tube.
11;0821 Pressure sensor(s) 114 tray reside at various locations in the system.
'Here, a pressure sensor is shown incorporated within the valve device near chest tube 104, and also near suction device 108. Pressure sensors may also be located in other places in the system, for example, near the chest. Pressure sensed at one or more location may be used to determine whether there is a change in pressure anywhere in the system, which may be used to identify drainage tube blockages and/or chest tube blockages. If an impediment is detected, an audible alarm may sound, andlior the controller may zunomatically control the valve device to clear the drainage tube and/or chest tube. More detail on this is provided below, 100831 Suction device 108 creates a negative pressure, or suction, force OD
the drainage tube (possibly via collection reservoir 116) which is in fluid communication with the valve device and chest tube. In this way, suction may be maintained on the chest cavity to promote chest fluid drainage and aid. with patient breathing. The mechanism for creating the negative pressure may be a pump or any other suitable mechanism.
100841 The controller may be incorporated into the suction device and/or the valve device and/or be separate. Any communication between the controller and the suction device and/or -valve device may be wired or wireless.
100851 Fig 2 slims another embodiment of the chest drainage: system with acti'eyalyes in the tube-tube interface ;:irea. In this embodiment valve device: 202 is located near, or incorporated into, suction device/controller 204. The valve device is connected to drainage tube relief lumen 206. Pressure sensor(s) (not shown) may be located anywhere in the system, including near the tube-tube interface 205. If drainage rube 208 becomes blocked, as sensed by the pressure sensor(s), controller 204 opens valve 212 to allow clearing of the drainage line. This may also occur at regular temporal intervals as a preventative measure. Valve 210 may also be closed to seal off the chest tube. If a pump is used, it. can assist with drainage by applying positive pressure to relief lumen 206 andlor negative pressure to drainae,e tube 208.
in this embodiment valves 210, 212, valve device 202 and suction device 204 are controlled by a controller which may be incorporated into the suction device and or valve device, or may be separate. Communications with the controller may be wired or wireless.
100861 Fig. 3 shows an embodiment of the chest drainage system with an active drainage tube relief valve and a passive chest tube relief valve. Chest tube 104 is connected to drainage tube 208. Drainage tube relief lumen 206 is in fluid communication with both chest tube 104

8 and drainage tube 208. The connection among the 3 lumens chest tube, drainage tube and drainage tube relief, mem at tube-tube junction 205, which is at or near the chest tube/drainage tube junction. hi some embodiments, the relief lumen may connect to the drainage tube or chest tube at a different location. The chest tube, drainage tube and drainage .. tube relief lumen may be connected with connection barb 31.4. Chest tube relief valve 302 may be incorporated into the chest tube, or a separate adapter designed to connect to the chest tube, for example, into connection. barb 314. In this embodiment, the chest tube has at least two lumens, as shown in F. 4. Pressure sensor 310, drainat:te tube relief lumen valve 304, and filterivent 312 are in fluid communication with drainage tube relief lumen 206.
Controller 308 includes pump 316, pressure sensor 310, drainage tube relief valve 304, filter/Vent 31.2, and fluid reservoir (or suction canister) 306, which is in fluid communication with drainage tube 208, [00871 Controller 308 may alSO include pressure sensor 318 on the canister side of the pump, in-line flow sensor 320 on either side of the pump, and/or one-way valve 322 on either side of the pump.
[00881 Pressure sensor 310 senses the pressure M tube-tube interface area 205 (via drainage tube relief lumen 206). When the drainage tube is blocked or restricted, the pressure in the tube-tithe interface area increases, 'When this pressure increases to a set pressure (generally, a negative pressure), controller 308 opens drainage tube valve relief 304 (wind) is normally dosed) to allow filtered atmospheric pressure air to enter drainage tube relief lumen 206.
This influx of air, in combination with the negative pressure in the drainage tube caused by pump 316, acts to clear the drainage tube of blockages/restrictions. Once the pressure in the tube-tubc interface area returns to normal, and/or after a set time, the controller closes drainage tube relief valve 304. Alternatively, the drainage tube valve may be a passive valve set to open and dose at set pressures.
(008)1 The mouitorlcontroller may monitor pressure inifbc drainaw *be relieflnrnon.pnti may pull additional suction in the fluid reservoiriStietion canister:asneeded to maintain the suction pressure in the proper range at the tube-tube interface area. For example, when the desired pressure is set to -20 cm1120, the monitor may activate the suction pump to keep the pressure at the tube-tube interface area between -15 0111.1120 and -25 01111120 or between -18 cm1120 and -22 crti1120. .1n another embodiment, the monitor may activate the pump and drainage tube relief valve 304 at regular temporal intervals as a preventative measure to dear arty pooled liquid from the drainage line, This is done by the controller activating suction

9 pump 316 while simultaneously opening drainage tube relief valve 304 to allow air to sweep accumulated liquid .into the suction canister via the drainage tube.
100901 The chest tube may become blocked or restricted. To clear restrictions, the suction magnitude applied by the controller to the drainage tube and experienced by the tube-tube interface ma.y be increased. When the pressure in the tube-tube interface reaches a set low evc.chcst tube relief valve 302 opens and. allows filtered. atmospheric air to enter the relief lumen of the chest tube (see Fig. 4 for detail). This influx of air, in combination with the negative pressure in the drainage tube and tube-tube interface area caused by pump 316, acts to dear the chest tube of bloekagesirestrictions. A passive valve is shown here; although an .10 active valve, controlled by the controller, may be used. Alternatively, a valve which is operated manually, may be used. Any of the operations disclosed herein which may be controlled by the controller, may alternatively be controlled passively, or manually. For example, valve functions, suction functions, etc.
100911 The chest tube relief valve may have a different opening pressure and closing pressure, For example, the chest tube relief valve may open at a higher pressure differential (i,e, a more nenative pressure in the tube-tube interlace area), and close at.
a lower pressure differential. This allows the valve to stay closed until a clear chest tube blockage is present and to minimize the flow resistance of the valve. Once the valve is open, this allows the valve to stay open to completely dear the tthest kibe blockage, even if the tube-tube interface area.
pressure increases so that the pressure differential across the chest tube valve drops below the valve opening pressure. in other words, the pressure within the tube-tube interface area may be more negative when a chest tube blockage is created, but less negative, as the chest tube blockage is being cleared, 10092.1 Fig. 3 shows one chest tube in use with the thot drainage system, but in some embodiments, more than one chest tube .may be used with the system. Each chest tube may have its own drainage lumen and relief lumen and valve.
100931 Fig. 4 shows an embodiment of the chest tube Shown .in Fig. 3_ Chest tube 104 includes drainage lumen 408 and chest tube relief lumen 406 incorporated into the chest tube.
Chest tube relief valve 402 and filter/vent 404 ate also shown in fluid communication with chest tubc relief lumen 406, which is in fluid communication with chest tube drainage lumen 408 via opening 412, Drainage openings 410 allow fluid from the chest cavity to enter the chest tube and drain through chest tube drainage lumen 408.

100941 During successful chest drainage, chest tube relief valve 402 is in the closed position.
in this position, fluid draining from the chest generally does not enter chest tube relief lumen 406 because of the fluid column in the chest tube relief lumen. A smaller diameter Chest tube relief lumen may help prevent fluid from entering the chest tube relief lumen.
The pressure in chest tube relief lumen 406 is slightly negative during chest tube drainage due to the negative pressure exerted by the pump on the drainage line, the chest tube drainage lumen, and to some extent, the chest tube relief lumen, The Chest tube may become blocked or restricted, because of blood clots etc. To clear them, the monitor may apply additional suction to decrease the pressure in thee chest tube drainage lumen, and ultimately, the chest tube relief lumen, to a more negative pressure. AS this negative pressure drops below a set valve opening pressure, chest tube relief valve 402 opens, allowing atmospheric (i.e., more positive pressure) to enter the system. This, in combination with the negative pressure exerted on the drainage lumen, clears the chest tube drainage lumen. Once the pressure in the chest tube relief lumen increases back to 3 set valve closing pressure, chest tube relief valve 402 closes and normal drainage continues. The chest tube relief valve opening pressure may be different than the Chest tube relief valve closing pressure to allow drainage of the chest tube. For example, the chest tube relief valve openin9, pressure may be at a higher pressure than the Chest tube relief valve closing pressure.
100951 For example, the chest tube relief valve may open When the pressure differential' across the valve is about -10 cmI120, about ,20 ernkl24: about -30 critH20,:
about -40 cmf-1.20, about -50 cinH.20 or as even high as about -100 cinT1.20, Or for example, the chest tube relief valve may open when the pressure differential across the valve is within a range of about -10 etull20 to about -20 cmf120, or within a range of about -20 etrill20 to about -30 cmH20, or within a range of about -30 cmf120 to about -30 em}f20, or within a range of about -40 cmH20 to about -40 cmH20, or within a range of about -50 cmH20 to about -100 cmi120.
100961 The chest tube relief valve may close at the same range, or at. a lower differential than the opening pressure. For example, the chest tube relief valve may close at a pressure differential of about to 0 cm112.0, about -5 cmH20, about -10 eml120, about -1.5 cull-1.20, or about -20 emH20, Or for example, the chest tube relief valve may close at a pressure differential range of about to 0 cad7120 to about -5 enaH20, or a range of about -5 etnli.20 to about -10 em1120, or a range of about -10 em1420 to about -15 cm}120, or a range of about -15 cm1420 to about -20 emi-120.

1.00971 The chest tube relief valve may take a variety of known forms, including but not limited to a check valve, umbrella valve, ball valve. Belleville valve, X-fratm valve, cross slit valve, or dome valve. The valve system preferably has a filter in place to prevent the entrance of bacteria or viruses from the atmosphere into the patient.
100981 In another embodiment of the chest tube, chest tube relief valve is active, not passive, and is controlled by the controller.
100991 In some embodiments of the chest tube,ehesttube relief valve is incorporated. into the:
chest tube. in some embodiments, the chest tube relief valve is incorporated into a connecter which is connected to the chest tube. In some embodiments of the chest tube, both the chest tube relief lumen and the chest tube relief valve are incorporated into a connecter which may be connected to a chest tube.
(Ø1.001 In some embodiments, chest tube .relief valve 402 takes the form of a magnetic check valve that has a substantial difference in the pressure differential required to open the valve, and the pressure differential required to keep the valve open or close the valve), thereby amplifying the toggling effect of the valve, This is preferable to increase the effectiveness of the clog clearance cycle, because it allows for a greater pressure differential when the air is sweeping the drainage lumen via the relief lumen than if the valve opened and closed at the same pressure. The valve is normally closed in order to maximize drainage of liquid as it enters the chest tube and to reduce the need for continuous pumping.
Fig. 5 shows a magnetic embodiment of the chest tube valve. The magnetic chest tube valve includes housing 502, filter 504, ferrous plate 506, gasket 508, magnet 510, seal plate 512, and positioning lip 514. When the pressure differential across the valve increases above a desired threshold, for example -50 eME120, the force caused by the pressure differential is enough to overcome the magnetic force between the magnet and the ferrous plate, thereby moving the two away from each other. Once the magnet and the ferrous plate move away from each other, the magnetic force rapidly diminishes, as the magnetic three is proportional to (1 r3). As a result, the amount of pressure necessary to keep the valve open is less than the 'pressure that was required to open it. This second pressure value, for example -10 cinft20, is determined by the maximum distance the magnet and seal plate can travel away from the ferrous .plate, which is in the exemplary embodiment shown in Figure 5 determined by positioning lip 514 in the housing, that sets this distance.
r.01.01...1 Fig. 6A shows the chest drainage system's ability to detect and clear pooled liquid in the drainage tube. In section 'A', a -10 einfi.20 vacuum is properly transmitted to the chest.

In section 'B', liquid begins to pooi in the bottom of the tubc, resulting in a decreased negative pressure (or an increased pressure). if unresolved clinically, drainage would be impeded. However, in section the drainage tube relief valve is opened and.
the liquid is flushed into the drainage container, resulting is restoration of proper suction in .Section as well as proper negative pressure as measured. The valve is closed after noirnal drainage/pressures have been restored. In this example, the pressure is measured at the tube-tube interface area, however pressure may be measured in other and/or additional locations in the system, For example, pressure may be measured at or near the chest or chest tube and also at or near the suction device, and the .differential pressure IlleaSlifernellt may be used to detect I 0 flow .impediments or pooling or clotting of blood!fluid, 101021 The controller can identitY impedime.nts to .fluid drainage via a measured absolute pressure, change in pressure, pressure differential between or among 2 or more locations, or at one location, When an impediment to fluid drainage is identified, an alarm may sound and/or the controller may initiate .eicaring procedures, including opening, and/or closing valve(s) in the chest drainage system, as described else:where herein The negative pressure in the drainage tube may be increased, or changed in other ways, such as pulsed, reversed etc.
1.01031 For example, if pressure measured at the tube-tube interface area is reading around -

10 cm1120 to around -20 ern1120 and the reading changes to zero to -5 cmi120, the controller may open the drainage tube valve to filtered atmospheric air, 'The controller may leave the valve in this position for a set period of time, say 5-10 seconds or 10-30 seconds and then may return the valve to its regular position. Alternatively, the controller may close the valve .when a set pressure i.s measured at the tube-tube interface area or elsewhere. The controller .may then cheek the pressure readings and if they have returned to normal., do nothing more. If they have not returned to normal, .indicating a blockage or slowing condition is still present, the controller may repeat the clearing procedure. This may be done repeatedly until the tubing is cleared. Alternatively or addition-ally, the procedure may change if repeat clearings are necessary. For example, the magnitude of negative pressure used by the suction device to clear the tubing may be increased, andfor the negative pressure may be pulsed.
The clearing procedure may be performed in response to the pressure readings and/or it may be done automatically on a periodic basis.
101041 Figs, 6B-6F shows the chest drainage systerds 'ability to detect And Clear pooled liquid in the chest be. Fig. 6B shows the pressure irt the chest drainage system over This pressure may be measured by the controller, preferably via -the dn-tinage tube .relief lumen, but can alternatively be measured elsewhere.
j01051 Section A of F. 6B Shows normal dminage at a negative pressure, created by the suction pump of the chest drainage system. Section B shows additional suction being pulled by the controllerfmonitor. This additiOrkal SUCtiOn may be pulled periodically., Or may be .pulic.c1 based on pressure readings in the system. For example, additional suction may be pulled when the presence of tidal oscillations is no longer detected in the drainage system by the controller. The additional suction transfers negative pressure to the drainage tube drainage lumen, the chest tube drainage lumen, and ultimately the chest tube relief lumen and .10 chest tube relief IUMen valve. When the pressure differential across the chest tube relief lumen valve reaches the valve opening pressure, the chest tube .relief lumen valve opens. The valve may open automatically if the valve is passive, or by the controller, if the valve is active, Section C Show S the pressure .when the valve is open. The valve may remain open for a set period of time. Alternatively, the valve may remain open until the controller senses that the clog has been cleared. The negative pressure, or suction, within the system, may remain steady during this phase, as Shown in Fin, 613, or the nep,ativc.s. pressure may become more negative, as shown in Fig. 6C, or the pressure may become less negative, as shown in Fig.
60.
101061 Section D shows the magnitude of the tegatiVe pressure docrtasiag as ..a resalt.of.a reduction in suction being pulled by the controtlerlintantot When the pressure in sygon reaches the valve's set closing pressure, the valve closes (or is closed) and fluid drainage continues in a normal manner. The valve dosing pressure may be at a lower magnitude .negative pressure than that of the opening pressure, as shown here. The valve closing .pressure may be at or near normal drainage negative pressure.
1.0071 Figs. 63-6D show different slopes of .negative pressures in different situations. In Fig.
6B the rate at which air is entering the system via the chest tube relief lumen valve is the same as the rate at which the suction pump is draining' the system during the open valve section C. in Fig, 6C, the rate of drainage is higher than the rate of air entering the system. in Fig_ 61), the rate of drainage is lower than the rate of air .entering the system. The slope of the pressure curve in section C may be controlled by the controller and the amount of suction that it is pulling, 101081 Fig. 6E shows an embodiment where the controller "overshoots" the normal draining suction pressure to dose the chest tube relief lumen valve. The valve closing pressure in this embodiment may be around .the normal draining pressure, or h may be at a less negative pressure (lower differential pressure).
101091 61' shows an embodiment where there is more than one chest tube.
In this embodiment, the first chest tube .retief valve opens when the pressure in the system reaches valve opening pressure. It Inay be necessary to increase the magnitude of the negative .pressure in the system further to open the second chest tube relief lumen valve. This is shown as valve 2 opening pressure on the graph. There may be 1, 2, or more valve opening pressures depending on how many chest tubes are used on a single patient. The closing pressures of the multiple chest tube relief valves may be the same, or they may be different.
The ability to detect the opening of the valves may be useful to determine whether one or more of the chest tubes is clogged, in which case an alarm or notification may be provided.
101101 in some embodiments, the chest drainage system may include a pH sensor.
Post, surgery inketion and empyema are of particular concern to clinicians. The pH
of =fluid drained front the body can be useful M diagnosing these, and other, conditions. To aid in the diagnosis, the chest drainage system may include a pH monitor in the controllers with a sensor in the reservoir, in the tubing, the pump, the valve device, or anywhere M the system.
The results may be display-ed on the display device. The system may also include a sampling port to sample the fluid drained from the chest. The system may also include iin infusion port to infuse an additive into the drainage fluid. These ports may be, in the reservoir, tubing, controller, valve device, or elsewhere in the system, lbr example at the chest tube / drainage tube interface.
101111 in an embodiment of the device shown in... Fig: 3 (or =
othet.embodiments diSelosed 'herein), the system is capable a measuring the flow rate Of 'air evacuated from the canisterlreservoir, in addition to pressure in the canister and pressure in the drainage tube .relief lumen. :Evacuation .flow rate may be used to determine the presence and rate of an air leak from the Chest cavity. The, evacuation flow rate necessary to maintain the systein at the prescribed suction levet is equivalent to =the flow rate of air entering the system (air leak), as the .flows of air into and out of the system must be equal in the presence of steady pressure.
Evacuation flow rate may be determined by the lbw rate of the air being evacuated from the canister via the integrated suction pump and the voltmie of liquid in the canister. These parameters may be tracked over time by the controller to .determine chest air leak presence and other parameters, such as air leak rate and changes to the air leak rate over time. Flow rate measurements are preferably made with any number of off-the-shelf sensitive air flow sensors that are known in the art. Flow at may alternatively or additionally be measured by -measuring the revolutions of the pump motor necessary to keep the suction at a prescribed level via a tachometer. Collected fluid volume measurements are preferably made with a non contact capacitive sensor, but may alternatively be made with optical sensors, pressure sensors, acoustic (such as ultrasonic) sensors, or any other liquid level sensing methods known in the art. In some embodiments, a capacitive sensor is mounted on the inside of the suction monitor and may use out-of-phase techniques to reduce interference front within the proximity, such as a human hand near or in contact with the container. Such a technique uses a level electrode, reference electrode, environment electrode, ground electrode, and two shield electrodes. In another embodiment, a compliant layer of material is present on either the suction monitor or the suction canister M the area of the capacitive electrode in order to minimize or eliminate any air gaps between the suction monitor and the suction. canister.
f01121 Drainage fluid volume may be measured. and tracked in the presence or absence of air leak determination.
101131 Example of Data Processing System 101141 Ha 7 :is a block diagram of a data processing syStetitt, which :May be used with Any:
embodiment of the invention. For example, the Systein 700 may be Used as part of a:
controller/monitor. Note that while FIG. 7 illustrates various components of a computer system, it is not intended to represent any particular architecture or manner of interconnecting, the components; as such details are not germane to the present invention. It will also be appreciated that network computers, handheld computers, mobile devices, tablets, cell phones and other data processing systems which have fewer components or perhaps more components may also be used with the present invention.
101151 As shown in FIG. 7, the computer system 700, which is a form of a data processing system, includes a bus or interconnect 702 which is coupled to one or more microprocessors 703 and a ROM 707, a volatile RAM 705, and a non-volatiie memory 706, The microprocessor 703 is coupled to cache memory 704. The bus 702 interconnects these various components together and also interconnects these components 703, 707, 705, and 706 to a display controller and display device 708, as well as to inputioutput WO) devices 710, which may be mice, keyboards, MOCIMS, network interfaces, printers, and other devices which are well-known in the art.
101161 Typically, the input/output devices 710 are coupled to the system through inputioutput controllers 709. The volatile. RAM 705 is typically implemented as dynamic RAM
(DRAM) which requires power continuously in order to refresh or maintain the data in the memory.
The non-volatile memory 706 is typically a magnetic 'hard drive, a magnetic optical drive, an optical drive, or a .DVD RAM or other type of memory system -which maintains data even after power is removed from the system. Typically, the non-volatile memory will also be a random access memory, although this is not required, 101171 While HG. 7 shows that the non-volatile memory is a locai de ce coupled directly to the rest of the components in the data processing system, the present invention may utilize a non-volatile memory which is remote from the system; such as, a network storage device which is coupled to the data processing system through a network interface such as a modem .10 or Ethernet interface_ The bus 702 may ilielude one or more buses connected to each other through various bridges, controllers, and/or adapters, as is well-known in the an, in one embodiment, the 1/0 controller 709 includes a USB (Universal Serial Bus) adapter thr controlling USB peripherals. Alternatively, 1/0 controller 709 may include adapter, also known as FireiWire adapter, lb-17 controlling FireWirc devices, SPI (serial peripheral interface), 12C (inter-integrated circuit) or UART (universal asynchronous receiverltransmitter), or any other suitable technology, r.0 MI Some portions of the preceding detailed descriptions have been presented in terms of algorithms and symbolic .representations of operations on data bits within a computer memory_ These algorithmic descriptions and representations are the ways used by those skilled in the data processing arts to most effectively convey the substance of their work to others skilled in the an An algorithm is here, and generally, conceived to .be a sell-consistent sequence of operations leading to a desired result. The operations are those requiring. physical .manipulations of physical quantities.
10119.1 It should be borne in mind, however, tharall. of-these and siniilar 'terms are to. be itssociated with the appropriate physical quantities and are merely convenient labels applied to these quantities. Unless specifically stated otherwise as apparent froin the above discussion, it is appreciated that throughout the description, discussions utilizing terms such as those set forth in the claims below, refer to the action and processes of a computer system, or similar electronic computing device, that manipulates and transforms data represented as physical (electronic) quantities within the computer system registeis and memories into other data similarly represented as physical quantities within the computer system memories or registers or other such information storage, transmission or display devices, 101201 The techniques shown in the figures can be implemented using code and data stored and executed on one or more electronic devices. Such electronic devices store and communicate (internally and/or witi other electronic devices over a network) code and data using computer-readable media, such as non-transitory computer-readable storage media (e.g., magnetic disks; optical disks; random access memory; read only memory;
flash memory devices; phase-change memory) and transitory computer-readable transmission .media (e.g., electrical, optical, acoustical or other form of propagated signals¨such as carrier waves, infrared signals, digital signals).
101211 The processes or methods depicted in the preceding figures may be performed by .10 processing logic that comprises hardware (e.g. circuitry, dedicated.
oic. etc.), firmware, software (e.g., embodied on a non-transitory computer readable medium), or a combination of both. Although the processes or methods are described above in terms of some sequential operations, 'tt Should be appreciated that some of the operations described may be pertbrmed in a different order. Moreover, some operations may be performed in parallel rather than sequentially.
r.01221 Various embodiments O1 23j Tn one embodiment of the chest drainage.Systeitiea balloon.aballoons may be used to cleat- the chest tube of clogs. In the normal drainage configuration, the balloons are deflated to minimize the space they occupy within the chest tube lumen and maximize drainage. For some examples, see PCT application PCTILIS15/52960 which is incorporated herein by reference in its entirety. Clogs may be detected by sensing pressure and/or pressure changes within the system. Clogs may he cleared when they are sensed, or on a. timed interval bases.
To clear clogs, the balloon(s) are inflated to urge clogs through the chest tube and toward the suction canister. The balloons may be compliant or non-compliant, or a hybrid of the two.
Compliant balloons may bc used to conform to the shape of the inner chest tube lumen, which may be .used to provide a seating of the chest tube if the drainage tubing is subsequently flushed with fluid (gas or liquid) toward the suction canister.
This seat prevents the flushing fluid from entering the chest: cavity. Alternatively, non-compliant balloons may be used to generate significant forces in order to compress and clear clogs.
This is especially useful with robust, or firmer, clogs.
101241 A combination of these 'balloons may be used 0 :achieve both objectives. For example, a non-compliant balloon may be coupled wth a compliant layer :as illustrated:*
'Fig. 8. 'Fig. 8 shows a balloon with compliant layer 802 and non-compliant layer 804. in another embodiment, the balloons may inflate directionally via valves botween the balloons, or may each have separate inflation lumens to inflate them each sequentially.
Alternatively, the balloons may be tapered in shape and setni-eompliant such that they &eetionally inflate against the inner chest tube lumen wall as they are inflated. This is shown M
Fig. 9 which shows balloon 902 as it is. inflated against the inside of the drainage lumen of chest tube 904.
101251 The balloon may also inflate directionally hi an accordion-like fashion, with the shape of the balloon and/or pleats to control the direction of inflation, as illustrated in Fig.10, which shows balloon 100.2 and the inner wall of the drainage lumen of the chest tube 1004.
101261 In another embodiment, the balloon may be built into the chest tube itself, such as a 1.0 coextruded inner wall that compresses inward as it inflates or expands to fill the chest tube drainage lumen, as illustrated in Figs. 11A and B. The figures show deflated balloon 1102, inflated balloon 1102, and chest tube drainage lumen .1104, Fig. 11 A shows a concentric configuration where Fig. I TB shows an offset configuration.
101271. In another embodiment, a balloon may be used to deliver energy to the chest tube and to any clogs within the drainage lumen of the chest tube to break up or dissolve the clogs.
This may include thermal .energy, light energy, acoustic energy, or microwave energy. In some embodiments, the balloon may have a reinforcing structure., such as a Nitinol coil, to:
increase the compression force against clogs, act as a chopping/breaking .meehanism, and/or act as a spring to control inflation direction/shape as discussed above.
Balloon inflation fluid may be a gas or a liquid. The inflation fluid may be sterile. If sterile, for example by delivering the fluid across a sterile membrane (for example one with pore size of 0.2 um) or storing the fluid in a sterile reservoir for inflation and deflation cycles, illustrated as 1202 in Fig. 12.
10128! Another embodiment of the drainage system makes use ituagnetic guidewirelO
clear the chest tube of dogs. The pick:wire is activated by enabling an external electromagnet such that the guidowire intermittently moves in and out of the chest tube, in similar fashion to a solenoid. This embodiment is illustrated in Fig. 13, which shows .inatmefic guidewirc .1302 and electromagnet 1304, as welt as clog .moving feature 1306 at the end of the 10129.1 Other erithodiments of the chest drainage system prevent adherence of clogs to the chest tube wall. In one embodiment, vibration energy, such as ultrasonic energy, is used. In another embodiment, the chest tube is made from, or coated with, a material to prevent adherence, such as, PTFE. In another embodiment, adherence prevention is accomplished by reducing the viscosity of the clots using coatings or drugs such as heparin or a =throttibolytie.
101.301 In another embodiment, a .flushing mechanism is inemporated into a balloon at the patient end of the chest tube, such that once the balloon is fully inflated, a flush port: is exposed to allow fluid to flush pooled liquid through the drainage tubing and.
into the suction canister, as illustrated. in Figs. 14A-14C. Balloon 1412 with flush port 1414 is shown in chest tube 1410. In one case, the flush port comprises micmholes in the wall of the balloon. Fig.
14A shows the balloon deflated. Fig. 1.4B shows the balloon partially inflated. Fig. 1.4C
shows the balloon fidly inflated and shows the flush fluid direction .within chest tube 1410, 101311 in another embodiment, multiple valves, such as balloon 'valves, are used to seal, or essentially seal, the chest tube so that suction can be applied to the drainage tubing and/or the chest tube To clear clots/blockages. The balloon(s) may also provide positive pressure to the chest tube and/or drainage tubing to flush pooled liquid into the collection reservoir while scaling the chest cavity from the positive pressure, as illustrated in Figs.
15.A-D, Fig. 15A
shows valve device 1500 with inner lumen 1502. The valve device may be part of the chest tube, or the drainage tube, or may be a separate device, preferably between the chest tube and the drainage tube. Balloon valves 1504 and. 1506 are shown, in addition to opening/port 1508, LUITICTI .1502 of the valve device is shown open in Fie. 15.A. The valve device .may operate with the following steps:
2.0 .. 101321 Step 1: Lumen .1502 is closed to the drainage tube by inflating (or closing) balloon valve 1506. The lumen remains open to the chest tube. A vacuum is exerted on the chest tube lumen by applying a negative pressure to lumen 1502 via opening 1508. The negative pressure applied to the Chest tube lumen is used to clear any blockage within the chest tube.
This step is shown in Fig. 1.5B.
101331, Step 2: Balloon valve 1506 is deflated (or opened) and balloon valve 1504 is inflated (or closed). Positive pressure is applied to lumen 1502 via opening 1508. This serves to force the blockage down through the drainage tube, without exerting any positive pressure within the chest cavity. This step is shown in Fig. 15C.
101341 Step 3: 'Balloon valve 1504 is deflated (or opened) allowing chest drainage to proceed normally. A valve and/or filter may be used in fluid conununication with opening 1508. This step is shown in Fig. 15D, 1.0135.1 These steps may be repeated multiple times to clear the chest tube.
The repetitions may be based on a pre-set schedule, or they may be set. based on whether the existence of a Chest tube 'blockage is sensed.
t01361 in some .embodiments, the patient end .of tbe..chest..tube is -vented to atmosphere,....ifor, example, via a chest tube relief lumen, to allow.:sterile.airu purge dogs fronfthe:thesttubt during step 1.
101371 Another embodiment of the drainage sySteM inakes...use..of a flush port for manual intermittent flushing of the chest tube and drainage,:line, as thwn in Fig:
.16A.. :Chest tube 1602 includes flush port 1604 and flush opening. 1606. in one embodiment, the flush port is 1.0 swabbable to ensure sterility prior to f1ushini4. In one embodiment, the drainage tubing is clamped and the flushing fluid is infused into the chest tube and into the pleural cavity, but subsequently drained once the drainage tubing is undamped arid the chest tube pat:they is restored. In one embodiment, the flush port cormects to a lumen, such as a chest tube relief linnet), that terminates at the patient (proximal) end of the chest tube such that the flushing fluid is infused through the chest tube toward the drainage tubing and suction canister with the drainage tubing -undamped by, sealing the chest tube prior to fluShing.
This may be accomplished by balloon 1608, or other -valve, located within the chest tube lumen, as shown in Fig. 16B, The flushing fluid may be air, water, saline, heparin, a thrombolytic agent such as tissue plasminogen activator, or any other suitable fluid.
f 01381 Another embodiment of the chest drainage system monitors physiologic parameters of inicrest. In one embodiment, pressure is .monitored. For example, internal chest pressure may be sensed and monitored to ensure the applied negative andlor positive pressure is being properly transmitted to the chest cavity. Or, tbr example, pleural and/or pericardial pressures may be monitored to track healing. Or, for example, differential pressure between the distal and proximal Olds of the chest tube may be monitored to ensure thest tube matey. Or, for example, the ,pressure at the distal (non-patient) end of the chest tube, for example at the proximal and/or distal end of the drainage tubing or collection canister, inay .be monitored for tidal oscillations, which are indicative of tube potency, 101.391 In some embodiments, the volume and/or flow rate of the drained chest fluid (either gas, liquid, or both) may be measured and monitored over time, in another embodiment, the volume and/or flow rate of an air leak (from the patient's lung) is measured to monitor wound healing. In another embodiment, pH of the drained .fluid is measured to monitor for infections. Additional parameters, such as conductance, spectroscopic signatures, protein content, and specific gravity of the drained fluid may also be measured to monitor patient recovely. Any of these measurements may be one time measurements or measurements made over =time. For measurements made and collected over time, the controller may analyze these data for trends. These data may be integrated with the hospital's eleeirOnie medical record system (either communicated to, or data may be obtained from) and/or displayed on a screen on the device or on a connected monitor, which may be connected either by wire or wirelessly, In some embodiments, alarms or notifications may be activated by the controller when the parameters surpass certain thresholds, which may be preset or set by the user. These .may be visual andlor audible alarms or notifications.. These data may also provide input to the 1.0 line-purging and clog-clearing functions of the device, such that, for example, line purging is activated When the suction at the chest drops below a certain level, or clog clearing is activated when tidal oscillations are diminished.
f01401 Another embodiment of the drainage system makes use of safety features to prevent dangerous pressures from occurring when inflating the balloons or flushing the chest tube and/or drainage tubing as described herein, in one embodiment, the pumps used to inflate or flush are connected to safety valves with crack pressures that are in the range considered to be physiologically safe, for example pre-venting suction below about -.20 cm1120, -40 cm1120õ or -70 cm1120, The pumps may be connected to pressure sensors with control systems to turn off the pumps if pressures are outside of the safe range.
101411 Another embodiment of the valve device includes a suction reservoir to provide additional suction to clear potential clogs from the chest tube, as shown in Figs, 17A-17D, Shown in these figures is valve device 1700, which may be placed between the chest tube and the drainage tube, or may be integrated into the drainage tube, or the chest tube. Valve device 1700 includes inner lumen 171.6 with lumen port 1706, chest,side valve 1702 with chest-side valve port 1704, .drainage-side valve 1712 with drainage-side valve port 1714, chamber 1710 with chamber port 1718 and -within the chamber is evandable valve 1708.
rtlit<121 In this embodiment, expandable valve 1708 is expanded by pulling suction (or applying negative pressure) within chamber 1710 via chamber port 1718. In this way, expandable valve 1708 can generate additional suction within the chest tube.
This suction is directed by additional valves 1702 and 1712, illustrated as inflatableideflatable balloon valves to temporarily seal lumen 1716. The sequence of events is:
101431 Step 11 Lumen 1716 is sealed via valve 17.12 to seal off chest tube from the drainage tube. This is done by applying pressure to valve 171.2 via port 1714, inflating -valve 1712 to dose off lumen 1716 on the drainage tube side of valve device 1700. This is shown in Fig.
17B.
101441 Step 2: Additional suction is applied to the chest tube by expanding valve 1708, This is done by applying suction to chamber 1710 via port 1718. This is also shown in Fig. 17B.
This applies additional suction to the chest tube, as indicated by the solid arrow in lumen 1716 in Fig,. 17B.
101451 Step 3: The chest tube side of the valve device is then sealed via valve 1702: by applying pressure to the valve via port 1704. This is, shownin 17C
101461 Step 4: The drainage tube side of the valve device is then opened by releasing the pressure applied (or applying a vacuum) to valve 1712. Expandable valve 1708 is also returned to its neutral state by releasing the vacuum applied (or applying pressure) to chamber 17W via pod 1718. Port 1706 (also described herein as drainage tube relief lumen port) allows filtered atmospheric air to enter lumen 1716. The release, or pressurization, of expandable valve 1708 may be enough to flush the drainage lumen of any blockage, so that fluid again may drain nonnally into the collection reservoir. If necessary, additional pressure may bc applied to lumen 1716 via port 1706 to flush the drainage tube.
Ahernatively or in addition, the negative pressure applied to the drainage tube may be increased (made more negative). This step is also shown in rig. 17C.
101471 Step 5: Valve 1702 is opened by releasing the prow applied (Or applying vacuum) via port 1704. Lumen 1716 is now fully open and drainage may resume as normal.
This is shown in Fig. 17D.
101481 These steps may be repeated as necessary to clear the drainage tube.
They may repeat at a set time interval. They may repeat continuously until the drainage line is cleared. They may repeat only as necessary, when the drainage tube is blocked.
101491 Port 1706 may be always open or may be controlled, for example by a solenoid, by the controller to opew'close as needed. The lumen to port 1706 is also described herein as the drainage tube relief lumen.
101501 All the ports shown in Figs, 17A- I 7D may entineet :to Eta which are controlled by the controller. The ports and/or lines may :include filtertimembranct toptveritebatatninateg from entering the system.
101511 In some embodiments, chamber 1710 and valve 1708 are not used and the components of the steps associated with the chamber and chamber valve are not taken.

1.01524 Figs. I8A and 18B show a method of measuring air leak using the chest drainage system. If the chest tube and drainage tube are clear of blockages, pressure within the chest can be measured and monitored by the controller to calculate the rate of air leak, As Shown in Fig_ 18A, the chest may be sealed off from the drainage canister, for example, using drainage-side valve 1.7/2, and pressure may be measured using a lumen in fluid communication .with the drainage lumen, such as via port 1706, or any other lumen in fluid conununication with the. chest tube lumen, for example a chest tube or drainage tube relief lumen, When the chest tube is sealed off form the vacuum source, the negative pressure in the chest tube lumen can be measured by .the controller, and will attenuate if the patient has ui air 1.0 leak. The attenuation can be measured by the controller over time and converted to a .rare of air leak (mLitain). A graph of the pressure within the chest tube over time in the presence of ail air leak is shown in Fig. 1813.
j01.531 An air leak may alternatively be measured by keeping both valves (1702 and 1712) open as shown in Fig. 19, and monitoring the pressure for spikes that result from bubbles in the water seal chamber in the suction canister. Pressure may be measured Via opening 1706 or any other area in fluid communication with lumen 1716, in a preferred embodiment, this method makes use of a sensitive pressure sensor that is connected in Line witi a high-pass filter in order to make the spikes from bubbling easier to detect. The various methods of air leak .detcetion described herein may be used independently or M combination.
101541 In another embodiment of the device, clog detection is performed by comparing the pressure measured within the chest (via the chest Mk relief lumen) and the pressure just distal to the chest tube (via the drainage tube relief lumen), i.e. in the tube-tube interface area.
These pressures may be compared to one another, and when they differ by certain amount, for example 5 emB20, this is indicative of a clog in the chest tube.
Alternatively, the pressure within the chest alone may be monitored, and when it increases by a certain amount, tbr example to above about 0 cmH20, this may also indicate that a dog in the chest tube exists. When a clog is detected, for example by either of these methods, the controller may automatically activate any of the clog-clearing mechanisms described herein.
Additionally, similar automation may be applied to the drainage line purging mechanism, by monitoring the pressure distal to the chest tube (via the drainage tube relief lumen), and activating a purge of the drainage line when the pressure increases above a certain threshold, for example -35, -30, -25, -20.45. -10, -5 or 0 cm1120.

1.0155.1 'Mien a clog is detected, the device may also warn the clinician of impending cardiac tamponade.
101.561 Fig, 20 illustrates an embodiment of the chest tube cross-seetion ii inore detail, showing, chest tube relief lumen 2002 and chest tube drainage lumen 2004. in sonic embodiment's, relief lumen 2002 may be significantly smaller in cross sectional area than drainage lamen 2004. The same may be true for the drainal,N tube relief hnnen and drainage lumen. For example, the cross sectional area of the drainage lumen of either the chest tube or the drainage tube may be about 5 to about 10 times larger than the cross section of the associated relief lumen. Or for example, the cross sectional area of the drainage lumen of .10 either the chest tube or the drainage tube may be about 10 to about 20 times larger than the cross section of the associated relief lumen. Or for example, the cross sectional area of the drainage lumen of either the chest tube or the drainage tube may be about 20 to 30 times larger than the cross section of the associated relief lumen. Or for example, the cross sectional area of the drainage lumen of either the chest tube or the drainage tube may be about 30 to 40 times larger than the cross section of the associated relief lumen.
r.01.57.1 Fig 21 Shows an .embodiment of the valve device.. Within the cylindrical housing are the balloon valves (includinn expandable valve) as illustrated in Figs. I 7A-D. Fig. 21 shows the valve device COTIllectilli4 points to .the chest aThe and drainage tube, as well as the relief Lumens. Barb 2102 connects to the drainage lumen of the chest tube, barb 2106 connects to the chest tube relief lutnen, the 5 pneumatic connecters 2108, 2110, 2112, 2114, and. 2116 connect to chest tube relief lumen barb 2106, chest-side valve port 17(4, lumen port 1706 (also described as the drainage tube relief port herein), chamber port 1718, arid drainage-side valve port 1714 of Fig. 17A respectively. The pneumatic connecters .may be in any order.
Barb 2118 connects to the drainage tube drainage lumen.. The other end. of the pneumatic connecters connect to the monitor/controller and the pneumatics are controlled by the controller.
rtill.581 fig. 22 further illustrates these relationships by showing chest tube 2202, relief lumen barb 2106, drainage tubing 2204 and pneumatic connecters 2106-2116.
101.59.1 Fig. 23 shows an embodiment of the chest drainage system in use, including chest tube 2302, drainage tube 2310, valve device 2304 and. monitoricontmlier 2306.
in this embodiment, the system is connected to standard suction device/canister 2308.
In this embodiment, the valve device is connected in line between the chest tube and drainage tube, with leads to the suction canister, and the monitor may be placed wherever is most convenient, .incinding but not limited to the patient's bedside, IV pole, or mounted to the suction canister directly.
j01601 The connection between the pneumatic connecters coming from the valve device and the monitor is illustrated in Fig. 24, which shows the monitor-side pneumatic connecter 2402, which connects to pneumatic connecters 2106-211.6 in Fig. 21. Pneumatic connecter 2402 connects the relief lumens and balloon valves of the valve device to the pumps and. solenoids housed within monitor 2404. The connecter preferably snaps into place, and seals against: the monitor with gaskets 2502 as shown. in Fig. 25. Preferably, the connections include membranes that act as sterile and/or liquid 'barriers to separate the lumens on the patient side .10 of the system from those on the monitor side, thereby preventing contamination. or liquid intrusion.
101611 in yet another embodiment, the chest tube clog clearance and drainage lino purging activities may be accomplished using a system shown in Fig. 26, in which a full length relief lumen 2604 runs the length of the system, from suction canisterfreservoir 2606, through drainage tube 2(10, through valve device 2602, through chest tube 2608 to the proximal tip (patient side) of the chest tube., in this embodiment, clot-is are cleared from the chest tube and pooled liquid. is cleared from the drainage Line hi the same step, by applying suctioi at the suction canister and opening the full length relief lumen to allow air to dear the entire system. Clearance of the line may be performed at set intervals, or When the pressure in the chest (measured via the relief lumen) increases above a. certain threshold, fOr example -35, -30, -25, -.20, -15, -10, -5 or 0 em1120, or a combination of these approaches.
Also in this embodiment, balloon valves may or may not be present in valve device 2602. if not present, air leak measurement can be accomplished by measuring the pressure in the entire system and watching for .attenuation as described herein. Alternatively, air leak can be measured by monitoring fo.r bubbles as illustrated .M Fig. 19. Alternatively, or ii iddition, air leak nuty be measured by measuring the air directly as it flows through the system with either an in-line flow sensor or by measurinnidetermininn the -volume of air moved by the suction pump to maintain adequate suction in the system. For example, a tachometer may be used to measure the number of revolutions of the motor driving the suction pump.
101621 In some embodiments, the controller is connected to a .iik...twork, either wired. or wireless, in order to transmit data for example to and/or from the patient's electronic medical record (EMR). The controller may also provide notifications of patient status on the controllertmouitor itself and/or by transmitting notifications and/or safety-alarms to the EMR

or the clinician's phone, tablet, watch., etc. Additionally, the system may interface with other systems via wireless or wired technolegy, and there may be wireless communication between the components, for example between the monitor shown in Fig. 24, the pneumatic connecter shown in Fig. 24, and/or the valve device shown in Fig. 21..
(Ø1.63.1 In another embodiment., the number of balloon valves may be reduced -.1riellor the relief lumen port may be integrated with the valve device at: a different location, N shown in Figs. 27A-27D. The steps associated with this embodiment are:
1.01641 Step 1. Inner lumen 2716 is sealed to seal the chest tube from the drainage tube. This is done by applying pos.itive pressure to chamber 2710 via Chamber port 2718.
This closes 1.0 expandable 'MINT 2708 sealing off lumen 2716, as shown in Fig. 27B.
[0165...1 Step 2: The drainage tube is flushed by opening flush lumen port 2706 to atmospheric 'pressure or applying .positive pressure to lumen port 2706. This is also shown in Fig, 2713.
t01661 Step 3: drainage-side balloon valve .2712 is then dosed by applying pressure to the balloon via drainage-side valve port 2714. 'This is Shown in Fig .27C.
.15 101671 Step 4: The chest tube is exposed to additional /locative pressure by applying negative pressure to expandable valve 2708 via chamber port 2718 of chamber 2710. Lumen port 2706 will be dosed during this step. This is shown in Fig. 7C. The chest tube (not shown) in this step preferably has a relief lumen that. is controllably opened to allow sterile air to enter the Chest tube drainage lumen from the patient end as additional negative pressure is applied, 20 which increases the effectiveness of cleAtrance, Lumen 2716 is now fully open and drainage may resume as normal_ This is shOW11 in Fig. 27D.
r.01681 in another embodiment, balloon valve 2712 may be removed such that the steps are:
r,C41 691 Step 1: Inner lumen 2716 is sealed to seal the chest tube from the drainage. tube. This is done by applying positive pressure to chamber 2710 via chamber port 2718.
This closes 25 expandable valve 2708 sealing off lumen 2716, as shown in Fig. 2713.
t0170.1 Step 2: The drainage tube is flushed by opening flush lumen port 2706 to .1t.mospherie pressure or applying positive pressure to lumen port 2706. This is also shown in Fig. 27B.
101711 Step 3: Clear the chest tube by returning the expandable valve 2708 to its neutral position and opening the chest tube relief ILIUM.), (not Shown) (via a valve, either passive or 30 active, not Shown) to allow air to sweep the drainage lumen of the chest tube.
101721 This approach eliminates the. need for balloon 2712. and valve. port 2714, which are only used when additional negative suction is pulled. Both of these steps may be performed by the, controller at regular intervals. Alternatively, the chest tube relief lumen and/or the drainage tube relief lumen may be 'kept open at all times, or optionally closed when manually capped by the user as desired or by the controller.
101731 In other embodiments, the action of seahrig.the balloon valvex.and gerierining.suctlop,.
its disclosed in any of the embodiments herein, May beverformed .manually by tbe userJar:
example, similar to the system shown in 'Fig. 12. In some embodiments, the manual valve connecter allows for attachment of one or more syringes, which can be used to seal the balloon valves and generate additional suction andSor positive pressure for purging the drainage line. In some embodiments, the manual valve device employs a valve that can be .10 configured to be 1) closed, 2) in communication with a chest,side or drainage-side balloon ValVe., or 3) in communication with the larger expandable -valve. In this manner, the user ma first connect to a balloon valve and apply positive pressure to create a seal, then connect to the larger expandable valve to generate ;Additional suction, The relief lumen described herein (either the chest tube relief lumen of the drainage tube relief lumen) can also be activated automatically or manually, or alternatively can be activated passively by means of a cheek valve that cracks once the pressure rises above a certain threshold, as described in detail herein..
101741 hi an alternate embodiment, the means of generating positive pressure and suction is within the valve device itself, such as a :fluid reservoir, so that a separate syringe is not required for activation, 1411751 In Figs. 28A-28C, a .method of measuring chest air leak is presented in more detail. In this embodiment, the chest tube and drainage tube aro kept dear thmugh the .methods described herein. An an leak may be monitored and quantified at both relatively high and low air leak flow rates. The applied standard suction causes the pressure in the chest to be negative, 101761 In the presence of relatively low flow rates, positive pressure is applied w. chamber 2810 via chamber port 2818 to dose expandable valve 2808 to seal turnen 2816 as <Sliowniti Fig. 2.813 The pressure in the chest is then monitored via lumen port 2814, if there is an air leak, the measured negative .pressure will become less negative as the incoming air enters the pleural space. Fig. 29 depicts an example pressure over time for two different low flow air leak rate measurements, The upper graph represents pressure attenuation over time in the presence of a small air leak, while the lower graph represents pressure attenuation over time in the presence of a 'larger air leak (still relatively 'low flow). The magnitude of the change in pressure is indicated by the slope of the line intersecting points 1 and 2.
The rate at which the pressure increases (APIAt) may be converted to volumetric air leak rate .(AVizit). Pons 1 and. 2 may be determined based solely on time, for example taking measurements 0,5 and 1 sec after creating =the seal as shown in Fig. 2813, Alternatively, they may be based on pressure values, cither absolute (e.g, once the pressure goes above -10 and -5 cm1-120) or relative (e.g.
once the pressure increases by 2 and 4 emlI20 relative to baseline). Sample benclatop data illustrating this technique is presented in Fig. 30, which utilizes a second degree polynomial fit to convert rate of pressure change to air leak, 10177) In the presence of relatively high flow rates, positive pressure is applied via balloon valve port 2804 to close balloon valve 2802 to seal lumen 2816, sealing off the drainage lumen of the chest tube from the drainage lumen of the drainage tube. This is shown in Fig.
28C. The. pressure is then monitored via lumen port 2814 to determine a baseline pressure -value due to the applied suction only (via negative pressure applied to the drainage nibe).
Then, balloon valve 2.802 is opened and a new pressure value is measured, once again via 1.5 lumen port 2814. lf the air leak rate is high., the will be a larger detectable difference between the two aforementioned pressure measurements due to the rapid influx of air. This is shown in Fig. 31. The upper graph represents a pressure differential in the presence of a relatively small air leak (though still high flow), while the lower graph represents a pressure differential in the presence of a larger air leak. The magnitude of the difference between these two measurements (AP) may be converted to volumetric air leak rate (AV/iSt). Sample .benchtop data illustrating this technique is presented in Fie.. 32, which uses a linear fit to convert rate of pressure change to air leak.
101781 The same methods a determining air leaks shown for low and 'high flow scenarios may also be perfomied by swapping the positions of the balloon valves in Fig.
28, relative to lumen port 2814. in this ease, the balloon valve seal is inflatedfelosed when .measuring low flow and the larger expandable valve is inflatediclosed -When measuring high flow.
[0179.1 One embodiment of the device may include a method for detecting the presence, as well as pmper placement, 1..)f the pneumatic cassette module (2402 in Fig. 24) in the .monitor (2404 in Fig. 24). This detection information may be used to start or stop .functionality of the device, activate or deactivate certain features of the device, sound alarms and/or display alert messages on the device, etc.
1.01801 One method for cassette .dctection may use an Infrared (110 emitter and receiver to detect the presence and proper placement of the cassette. This IR sensor may measure the .reticctivity of the cassette surface; the information may be used to inform device function.
The reflectivity of the cassette may be modified to allow for a wide variety of reflectance values. The reflectivity of the cassette may be controlled by changing the color, geometry, or trty combination of color and geometry to adjust reflectance. In Fig. 33, the relationship .. between color and reflectance readings is shown, where the possible range of values may be 0-100%, In Fig., 34, the relation between surface angle and reflectance readings is shown for a white surface where again, the possible range of values may be 0-400%.
101811 Another method for cassette .detection may use a color sensor with attached LED to illuminate the surface to be measured. This color sensor may be capable of detecting various .10 levels of a specific color, such as red and/or cyan, light intensity, light temperature, as well as any combination of these metrics. tn one embodiment, the color of the cassette may be used to differentiate between two or or desired function settings of the device. In another embodiment, the cassette my have features whieh allow a certain amount of light to reach the sensor, thus, variable light intensity may be used to control fin:tenon settings of the device.
.. In another embodiment, the cassette may have features which modify the temperature of the light reaching the sensor, a Light filter for example: thus, variable light temperature may be used to control function settings of the device.
101821 Another .method for cassette detection may use a Hall Effect sensor to detect the presence of a magnet located th the cassette. This .magnotic sensor may be used to ensure complete and proper placement of cassette to locked-position in monitor by defining placetnent of the magnet and Hall Effect sensor, such that detection only occurs when the cassette is fully seated and locked in place.
101831 Another method for cassette detection may use an IR gate sensor to detect both the presence of the cassette in the monitor, as well as ensuring proper placement in the monitor.
The cassette may include a feature or .feaiures which may interact with the IR
gate sensor, providing information regarding the placement of the cassette in the monitor.
10184.1 Another method for cassette detection may utilize a IN light sensor to detect the 'presence and proper placement of the cassette in the monitor. TO allow for variability between cassettes, features may be added to the cassette which modify the amount of UV
light permitted to reach the sensor. This may be accomplished using, for example, .13N/ filters, passageways within the cassette, openings, minors, or some combination of these features.
1.0185.1 Another method for cassette detcedon may involve capacitive sensing, whereby the cassette has varying IONTIS of dielectric strength depending on, for example, the size of a strip of nwtai embeddcd in or mourned to the cassette. A capacitive sensor within the monitor may then be able to distinguish between the various cassettes depending on this vaiying level. of capacitance.
t01861 One embodiment of the device may include a. method for measuring and .quantifying air leak .metrics which are then displayed via :a .seneen. on the monitor or elsewhere., This information may be used to start or stop functionality of the device, activatedeactivate certain features of the device, sound alarms and/or display alert messages on the device, provide information to attending physicians, as well as other actions related to proper removal of fluids from the chest. These actions may be performed manually or automatically .10 be the controller, 101871 On method for displaying air leak data May:
inehtde:.:deScribing:theOeturtence oft particular air leak qualifier by showing the pereentage:of theaStirenients.
ever :the preViOns :X
hours for which that qualifier occurred. The an leak qualifiers may include/he equivalent to:
"Persistent" for high flow, "Intermittene for moderate to low flow, and "None for no flow.
As shown in Fig. 35, this infotmation may be presented:, for example, graphically as a bar graph. 3502 or circular chart 3504, or in a display using text and numbers (3504 101881 Another method for presenting air leak data may include graphing trending flow rate data over a period of time, for example I 48 hours. The air leak flow rate information may be collected, for example, using an in-line .flow sensor, pressure sensors, or pump tachometer.
.As shown in Fig. 36, the air leak flow rate trending data may be expressed as (m/min) with respect to time in hours past, for example. The pressure shown here is measured at the barb Or tube-tube interface.) area.
rt:11.891 Another .method tbr presenting air leak data may include graphing trending air leak qualifiers over a period of time, for example ¨ 48 'hours. The air leak qualifier information may be calculated, for example, using algorithms to relate changes in chest or chest tube pressure to -volumetric flow rate, or defining a pressure threshold, for example -5 cm1120, and relating the time to reach that value with a qualifier. As Shown in Fig.
37, the air leak qualifier trending data may be expressed as, for example, "Persistent", "Intermittent", and "None' with respect to fink: in past, tbr example, for .the past x hours.
10190.1 Another method for presenting air leak data may include an instantaneous measurement initiated by, for example, pushing a button. As shown in Fig. 38, the prompt for instantaneous measurement may be a highlighted arrow, a physical button, a virtual button, graphic etc. 'The information provided may be in the form of, for example, flow rate (mliinin) or an air leak qualifier, such as "Persisted', "Intermittent", "None", or an equivalent term.
101911 One embodiment of the de-vice may include a method for measuring and quantifying dm; clearance metrics to he displayed via a display or screen. This information may he used .to start or stop functionality of the device, activate/deactivate certain features of the device, sound alarms and/or display alert messages on the device, provide information to .attending physicians, as well as other actions related to proper removal of fluids from the chest.
10192.1 One method for presenting clog clearance. data .may include displaying the number of dogs cleared over a certain amount of time, for example 1 ¨ 48 hours ¨ the .range may be set 1.0 by the user or may be pre-set. As shown. in Fig, 39, the information displayed may iriclude description of the displayed metric, for example "Clogs Cleared", a nuinber or quantifier associated with the .metric, fbr example, the number of clogs cleared, and the time interval over which the metric occurred.
101931 Another method for presenting dog Clearance data May 'for.
tpmpie, 15 displaying the time for when the last clog occurred, the date on which the lag clog Oceurred, whether the clog was cleared, the tiime. passed since the last clog occurred, or some combination of these or similar metrics. As shown in 'Fig. 40, the information displayed may indicate what metric is being shown, for example "Last Clog".
101941 Another method for presenting clog clearance data may include a graph displaying 20 trending pressure data from the tube-tube interface area, or elsewhere in the system, over a certain amount of time, for example 1 --- 48 hours, for a certain range of 'pressures, fbr example -500 500 cmf120. As shown in Fig. 41, one or more pressure values may be plotted simultaneously with respect to ti.me, for example, pressures measured at different locations within the system. For example, the graph my display the applied suction level ,set 25 by the user, shown by the solid line, and/or the graph may display the pressure measured in the tube-tube interface area, shown by the dashed line, 101951 Another method for presenting clog clearance data may include a graph displaying trending clog clearance data for a specific time interval (for example, 1 hour), over ;a =Min amount of time, for example I ¨ 48 hours. As shown in Figõ 42, a bar graph may be. utilized 30 to convey information regarding the number of clogs cle,4,1red each hour over the past 10 hours, for example. The total number of dogs cleared over the total duration of device use fbr a particular patient may also be shown.

101961 Some embodiments disclosed herein include a balloon, or pneumatic, valve, which uses pressure variance to occlude or open the passageway by inflating or deflating a flexible membrane, or balloon. Figs, 43A-43E show an embodiment of these types of valves. The valve includes rigid housing 4302 and thin-walled silicone extrusion 4304, as Shown in Figs 43A-E. Silicone extrusion 4304 may be either an extrusion or a. mold out of any suitable material, including silicone, latex, polymer, etc. The durometer of the silicone may be, for example 20A-70A, and the wall thickness, for example 0.005" ¨ 0.050". The wall thickness may be adjusted to achieve the desired sealing pressure. The wall thickness may be consistent along the length or vary along the length. The length of .the silicone extrusion may be 0.5" ¨
1.0 1.0" and the inner diameter of the silicone extrusion may be 0.1" ¨ 0.50", In one embodiment example of the balloon .valve, assembly begins by inserting the silicone extrusion through the center of the balloon housing. Next, the extrusion is folded up and over the edge of the 'housing on both ends as shown in Figs. 43B and 43C. This process may be done several ways, for example, manually folding the extrusion. Another process may Maude inserting a.
.15 balloon through the center of the extrusion; upon placement, this balloon could be inflated, effectively expanding the silicone membrane until it folds over the edge of .the housing.
Another process may incorporate a fixture which has two or more grasping features that expand radially in and out; the grasping features are used to grab and expand the silicone extrusion; once the extrusion is stretched, the housing may be moved forward to accomplish 20 the folding process. As shown in Fig 43C and 431), once the extrusion is folded over the housing, two 0-rings are placed over the silicone extrusion to ensure that the silicone membrane remains in place and is sealed with respect to the housing. Figs. 43 D and 43E
show the finished balloon valve.
101971 One embodiment of the chest drainage system may include vent/filter membranes in 25 line with the pneumatic tubing for the purpose of controlling quality of the air or adding dampening to the system. These membranes may have variable thickness, for example 0.001"
0.010", have variable pore sizes, for example 0.2 100 micron, have variable cross sectional areas, for example 0.01 ¨ 0.1 in2, and have different cross sectional shapes, for example circular or rectangular. The membranes may be placed within the cassette, in line 30 with the pneumatic tubing via barb connection, within the monitor, or within the valve device. These vent membranes may be attached in many ways, for example ultrasonic welding, via a separate housing, or UV cure adhesive.

1.0198.1 One embodiment of the chest drainage system .may include a -feature which allows the monitor to be mounted in a convenient and effective location during use in -various hospital settings. This connection feature may be modular: the monitor may have a feature that can connect to many different: attachments that offer different mounting solutions. One iteration of the modular design may include a snap-and-lock .featurc, where the attachment locks into place and can be released, for example, by pushing a button to disengage the lock. Another iteration may include a threaded hole in the monitor that interfaces with a threaded rod on the attachment Yet another :iteration may include a sliding mechanism where the attachment grabs onto .rails or -hacks to connect with the monitor. Another iteration may include a push-and-lock feature, where the attachment can be locked and unlocked by pushing it further into the connection, similar to an SD card. Another iteration may include a single or series of magnet(s) which properly orient and hold the attachment firmly to the monitor.
I01.991 One method for creating a mountirig 17eature may include the use of a rigid bracket on which a pair of hook features are connected. As shown in Fig. 44, bracket assembly 4402 may connect: to the monitor via one of the modular mounting options 4404.
Hooks 4406 may be attached hi such a way that they are able to pivot to provide increased adaptability.
[02001 Another method for creating a mounting feature may include the use of flexible straps in combination with a hook feature. As shown in Fig. 45, straps 4502 may be attached to the base of monitor 4504 and cover the sides of the monitor, with hook features 4506 integrated with the strap. These straps may be fixed or mo-veable, for example, they may be able to retract inside of the monitor When not in use. In this case, the hook features may have a place to be stored as welt for example external wells into which the hooks click in place.
102011 Another method for creating a inounting feature may :include the use of flexible tubing to provide a highly adaptive solution with many potential uses. As shown in Fig. 46, tubing 4602 may be able to take many shapes by simply beading the tube to mate a desired shape or feature, such as hook shape 4604. These tubes may be attached to the monitor on the back or sides, using one of the modular mounting options described herein. The force required to bend the tubing is low enough to not require a special tool, whilc simultaneously being stiff enough to hold its shape under the loads placed on it by the monitor and additional external forces.
102021 Figs. 47, 48, 49 and 50 show an embodiment of a dual-lumen chest tube.
'010 tube 4702 may be made using silicone, PVC, or odwr,:$4.,iiabie matpriO1 wit.h...a.:0able dUrometer, for example 20A ¨ 80A. The effective outer diameter of the chest tube may vary between Ur -- 40Fr. The chest tube shown in Fig. 47 may include three sections: a chest tube region, as shown in Fig. 48, a transition region, as shown in Ha. 49, and a pull-through -region, as shown. M Fig. 50. The chest rube region comprises a dual-lumen extrusion with holes 4802 near the patient side for drainage of fluid .from the body. The chest tube region is preferably capped with rounded tip 4804, but may also have an open patient end without a cap. The transition region separates the two chest tube lumens, for example chest tube drainage lumen and the chest tube relief lumen, into separate tube sections that are more easily attached to barbed connectors. Fig. 49 shows chest tube drainage lumen tube section 4902 and chest tube relief lumen tube section 4904. Specifically, at the non-patient end of the transition region, 1.0 both ltnen preferably become circular to allow for proper attachment to standard barbs. The pull-through region shown in Fig. 50 includes chest tube drainage lumen tube section 4902 and chest tube relief lumen tube section 4904. The two tube sections may also be joined, for example with .webbing or adhesive. The ends of the two tubes may be tapered to allow for easier insertion into the chest and also easier pulling of the chest tube through, from the inside to the outside, the chest wall Alternatively, the tubes may not be tapered or only one of the tubes may be tapered. In some embodiments, the relief kilMen tube may "dive" into the larger tube so the outer profile on the non-patient end is just that of the drainage tube. This is shown in Fig. 51. The relief tube is also .preferably sealed near the non-patient end, for example with a plug of silicone, in order to prevent fluid ingress into the relief lumen as the tube is 'pulled through the patient wall.
102031 in some embodiments, the device is configured such that when the pneumatic connecter is disconnected from the monitor, the lumens enter a safe state.
This safe state may include closing off either or both of the chest tube .relief lumen and the drainage tube relief lumen to prevent air from continuously entering the system, 'The safe state may also .inelude opening the balloon valves and expandable valve in the valve device so that the inner lumen remains open allowing fluid drainage to continue without obstruction. To ensure the balloon valves enter and remain in a safe state, their ports at fluidly lied to the chest tube raid lumen and/or the drainage tube relief lumen when disconnected from the monitor. .rn this way, the pressures on both sides of the balloon valves are equal and the balloon valves therefore remain in an open state, This is illustrawd in Fig. 52A and 5213, where Fin. 52A
shows the connections in the. connected state and. Fig. 5213 shows the.
connections in the disconnected state.
'15 1.02041 hi one embodiment: the .mechanism illustrated in Figs. 52A and 5213 is accomplished by means of a manifold design shown in Fig. 53. in this design, manifold 5302 may be used to either; A) independently connect the lumens to their respective gasket when connected to the monitor, or B) tie the balloon seal lumens to the flush and/or relief lumens when disconnected to the monitor by means of a sliding mechanism that is activated when disconnected from the monitor. This mechanism is shown in Fig. 54 and may include springs within the connecter that .kcep the lumens in a safe state unless connected to the monitor, The safe connection/disconnection may also be achieved by other means.
1020.5) Fig. 55 Shows an alternative configuration to the system depicted in Fig, 24, Fig. 55 .10 shows a pneumatic connecter which connects to the monitor by being placed into its receptacle and then slid into place, thereby making the independent lumen connections. The connecter is held in this position by means of a latch that can be disengaged by the user when mmoving the connecter. This allows the various lumens to enter the sale state when disconnected.
102061 In another embodiment, the same effect of providing a safe state for the lumens is achieved by spring-activated valves that either provide independent paths for the lumens to conaeet to their respective gaskets, or seal or tie the lumens together. An example of an individual such valve is shown in Fig, 56, and it-id-Wes 0-ring 5602 and spring 5604 in both the .connected and disconnected (safe) state. Fluid path $606 is closed in the connected state and open in the disconnected (safe) state.
102071 In another embodiment, the .m011401- is capable of keeping the pneumatic comccter comccted until the device is in a safe. state (i.e. balloon -valves are open).
Another way of saying this is that the pneumatic connecter cannot be disconnected until the monitor has determined that the system is in safe mode. This may be achieved by mechanical means, such ts a latch that the .monitor itself engages with the pneumatic connecter when sealing the balloon -valves. This may be accomplished using a solenoid valve, motor, or any other suitable means.
102081 In another embodiment, the pneumatic: Coinicetets...-thay be:
diSeonneeted -valve device shown in Fig. 21 to achieve a safe....dikoanceted StaWasidescribedabove This is:
preferably achieved by the .mechanisrn shown in Fig. 57. To remove pneumatic connecters 5702 from valve device 5704, for example when transferring the patient from the ICU to the step-down unit when active clog clearance and line purging is no longer required, pneumatic connecters 5702 may be disconnected from the valve device 5704. in this .embodiment, slider 5706 is moved to tie the lumens to their respective safe states as shown in Fig. 52. The same slider also disengages a latch that. keeps the pneumatic connecters in place, thereby allowing the connecter to be removed from the valve device while allowing the lumens in the valve device to remain in a safe sate. In some embodiments, once the pneumatic connecters have been removed, the valve device and/or the pneumatic connecters are locked to prevent re-attachment of the pneumatic, connecter after it has been disconnected.. This may be accomplished, for example, by a latching mechanism that only engages when the slider is in its fully open position.
102091 in some embodiments, the chest drainage system includes the monitor/controller .10 shown in Fig, 58, In one etribctdiment, the Monitor includes screen 5802, integrated pump (not shown) and mating ports between suction canister/reservoir 5804 and monitor 5806, including ports to provide suction to the reservoir, open the drainage tube relief lumen valve via integrated, solenoid or other means, and. capturctsceure the drainage tubing and suction canisteL in some embodiments, the Pneumatic lines are protected by :nen integrated into the canister itself to prevent egress of liquid from the canister.
[02101 In some embodiments, the suction canister/reservoir is protected from liquid egress by means of a tortuous path created by the internal geometry of the SUCti011 canisterireservoir as shown in Fig. 59. The tortuous path may include a series of ribs 5904 and channels 5902 to separate the fluid collection chamber of the reservoir from the vacuum/suction port which connects .to the monitor. The tortuous path geometry makes it more difficult for liquid to reach the suction port regardless of monitor orientation 10:21.1.1 in some embodiments, an acederatileta is 'used to monitor orientation of the monitor and the controller provides an alert when the monitor is in a position that may compromise the suction port. In this example embodiment, the drainage tubing is first connected to the drainage canister and the drainatic canister is then connected to the monitor.
Alternatively, the drainage tubing drainage lumen andfor drainage tube relief lumen may be connected to the monitor itself, and/or the two tubes (drainage tube drainage lumen and drainage tube relief lumen) may be connected separately. Jn the exemplary embodiment shown, the canister/reservoir is connected to the front of the monitor, bat in other embodiments may be connected to the back or either side of the monitor, or be separate. .1n. one embodiment, the suction canister/reservoir has a latchirto hinge that mates with a latch on the suction monitor -as shown in Fig_ 60, such that once the canister is connected to monitor 6008, hinge 6004 .must be manually depressed in order to disengage latch 6002 and remove canister 6006 from monitor 6008.
l021.21 In another embodiment of the device Shown in Fig. 61, the monitor has modular attachment receptacle 6102 for accepting any number of accessories for mounting or handling the device, including, but not limited to bed mounts, IV pole mounts, carrying straps, or handle 6104, as shown in Fig. 61 . In another embodiment, the device may have multiple such attachment receptacles to allow for multiple accessories to be connected at once, for example but not limited to a bed mount and a handle or a handle and carrying straps.
102131 In some embodiments, the chest drainage system .may be used with a standard .ehest 1.0 tube without a chest tube relief lumen. In this case, the drainage tube relief lumen and drainage tube ltilfilen join tc.igether at a connection barb between the drainage tube and the chest tube. An example of this type of counection barb is shown in Fig. 62.
The connecter includes chest tube connecter 6202, drainage lumen connecter 6204 and drainat.>::e lumen relief lumen connecter 6206. This connecter arrangement may be particularly appropriate in thoracic surgery where there is less concern of clogging within the chest tube, and clearance of the drainage line to maintain suction pressure is the primary concern. In another embodiment, the same type of .connection barb may be used with a chest tube with a chest tube relief lumen .that includes any of the passive valves described above and in Figs. 4 and 5.
hi this configuration, the passive VaiVCS are normally closed, but the pump hi the monitor may generate additional suction. at temporal intervals (or when a blockage is sensed.) in order to surpass the crack pressure of the valve such that it opens and air can sweep the chest tube drainage lumen clear via air from the chest tube relief lumen This activation may alternatively or .additionally occur when the monitor detects that: the magnitude of tidal oscillations has diminished, indicating that a blockage is forming within the chest tube. The suction .monitor may also temporarily reduce the suction magnitude after such an activation is performed in order to ensure that the passive valve closes again.
102.141 In one em.bodiment of =the chest drainage system, controllerlmonitor screen 6302 has touch capability for user input. Alternatively the monitor may employ an array of buttons. An example touchscreen image is shown in Fig. 63. Touching this screen will result in an appropriate response by the triOnitOr, for example touching "suction" takes the user to a screen to adjust the suction value, touching "mode" allows the user to switch between drainage and air leak modes, and touching "drainage" or "air leak" takes the user to a plot of that metric over time, as shown in Fig. 64. When the monitor is showing a.
graph, touching .the x-axis may change the time scale and touching the y-axis may change the flow rate or volume scale .(depending on which plot is shown).
1021.9 hi another em.bodiment of the pneumatic connecter/monitor interface, the device may check for proper seating of the pneumatic connecter with the monitor by performing a self -pressurization cheek and monitoring for a pressure response that is indicative of a properly-seated connecter. This technique may also be used to detect various sizes of canisters..
1.0216.1 In some embodiments of the chest drainage system, the monitor provides pulsatile suction (whether via the valve device or via the pump in the monitor to maintain chest tube p.ateney. This suction may be in the farm of a sine wave, square wave, or any other suitable 1.0 oscillatory wavetbrmõ and may oscillate between, for example but not limited to 0 to -40 cmli20, 0 to -60 cm1-120, 0 to -80 cm/1.20, 0 to -100 cmkI20,. -10 to -40 ctuff20, -20 to -60 cm1-120, and so on. These embodiments may or .may not include a chest tube relief lumen, 102171 Any of the embodiments disclosed herein may be adapted to .funetion with more than one chest tube, fbr example, by connecting more than one chest tube to the valve device or the connection barb,

Claims

What is claimed is:

1. A drainage system, comprising:
a tube configured for insertion into a body of a subject wherein the tube defines a tube relief lumen and tube drainage lumen in fluid communication with one another; and a tube relief lumen valve in fluid communication with the tube relief lumen such that a pressure differential is ruled between an ambient pressure and the tube relief lumen, wherein the tube relief lumen valve is configured to close at a first pressure differential and to open at a second pressure differential which is different from the first pressure differential.

2. The system of claim 1 wherein the tube comprises a chest tube defining one or more drainage openings in fluid communication with the tube drainage lumen.

3. The system of claim 1 further comprising a drainage tube in fluid communication with the tube drainage lumen.

4. The system of claim 3 further comprising a drainage tube relief lumen in fluid communication with the tube drainage lumen or the drainage tube.

5. The system of claim 4 further comprising a drainage tube relief lumen valve: in fluid communication with the drainage tube relief lumen.

6, The system of claim 5 wherein the drainage tube relief lumen valve comprises a passively operated valve.

7. The system of claim 5 wherein the drainage tube relief lumen valve comprises an actively operated valve.

8. The system of claim 3 further comprising a fluid reservoir in fluid communication with the drainage tube.

9. The system a claim 1 wherein the second pressure differential to open the tube relief lumen valve is greater than the first pressure differential to close the tube relief lumen valve.

10. The system of claim 1 wherein the tube relief lumen valve comprises a passively operated valve.

11. The system of claim 1 wherein the tube relief lumen valve comprises an actively operated valve.

12. The system of claim 1 wherein the tube relief lumen valve comprises a magnetic valve.

13. The system of claim 12 wherein the magnetic valve comprises a housing having a first element secured with the housing and a second element attached to a seal wherein the seal has a first position in ,which a magnetic force between the first and second attractive elements is greater than the first pressure differential and maintains the magnetic valve in a closed configuration, and wherein the seal has a second position in which the magnetic three is less than the second pressure differential and maintains the magnetic valve in an open configuration,

14. The system of claim 13 wherein one or both of the first and second elements comprises a magnet.

15. The system of claim 1 further comprising a controller in communication with the

16. The system of claim 15 wherein the controller is configured to monitor a rate of air flow from the tube drainage lumen as an indicator of a thoracic air leak.

17. The system of claim 16 wherein the controller is configured to determine at least one parameter of the air leak.

18. The system of claim 16 father comprising a flow meter in communication with the controller.

19. The system of claim 16 wherein the controller is configured to monitor a number of revolutions of a vacuum pump in fluid communication with the tube drainage lumen.

20. A method of maintaining a drainage system, comprising:
providing a tube having a tube relief lumen and tube drainage lumen in fluid communication with one another and configured for insertion into a body of a subject, and a tube relief lumen valve in fluid communication with the tube relief lumen; and configuring the tube relief lumen valve from a closed configuration into an open configuration, where the dosed configuration is formed when a first pressure differential between an ambient pressure and the tube relief lumen is created and where the open configuration is formed when a second. pressure differential between the ambient pressure and the tube relief lumen is created.
wherein the cult pressure differential is different from the second pressure differential.

21. The method of claim 20 further comprising draining a fluid from a body cavity of the subject via one or more drainage openings in the tube drainage lumen and through a drainage tube.

22. The method of claim 20 further comprising controlling a flow through the tube relief lumen via the tube relief lumen valve.

23. The method of claim 20 further comprising a drainage tube relief lumen in fluid communication with the tube drainage lumen,.

24. The method of claim 23 further comprising a drainage tube relief lumen valve in fluid communication with the drainage tube relief lumen.

25. The method of claim 24 wherein the drainage tube relief lumen valve comprises passively operated valve.

26. The method of claim 24 wherein the drainage tube relief lumen valve comprises an actively operated valve.

2. The method of claim 20 wherein the second pressure differential to open the tube relief lumen valve is greater than the first pressure differential.

28. The method of claim 20 wherein the tube relief lumen valve comprises a passively operated valve.

29. The method of claim 20 wherein the tube relief lumen valve comprises an actively operated valve.

30. The method of claim 20 wherein the tube relief lumen valve comprises a magnetic valve.

31. The method of claim 30 wherein the magnetic valve comprises a housing having a first element secured with the housing and a second element attached to a seal, wherein the seal has a first position in which a magnetic force between the first and second elements is greater than the second pressure differential and maintains the magnetic valve in a closed configuration, and wherein the seal has a second position im which the magnetic force is less than the first pressure differential and maintains the magnetic valve in an open configuration.

32. The method of claim 31 wherein one or both of the first and second elements comprises a magnet.

33. The method of claim 20 further comprising a controller in communication with the tube drainage lumen.

34. The method of claim 33 further comprising monitoring a rate of air flow from the tube drainage lumen via the controller as an indicator of a thoracic an leak.

35. The method of claim 34 further comprising determining at least one parameter of the air leak via the controller.

36. The method of claim 34 further comprising a flow meter in communication with the controller.

37. The method of claim 34 further comprising monitoring a number of revolutions of a vacuum pump in fluid communication with the tube drainage lumen via the controller.

38. A drainage system, comprising:
a tube configured for insertion into a body of a subject, wherein the tube defines a tube relief lumen and tube drainage lumen in fluid communication with one another;
a tube relief lumen valve in fluid communication with the tube relief lumen;
a suction pump in fluid communication with the tube drainage lumen; and a controller in communication with the tube, wherein the controller is programmed to actuate the suction pump at a first level of suction which maintains the tube relief lumen valve in a closed configuration and at a second level of suction which reconfigures the tube relief lumen valve to an open configuration.

39. The system of claim 38 wherein the tube relief lumen valve is configured such that a pressure differential is formed between an ambient pressure and the tube relief lumen, wherein the tube relief lumen valve is configured to close at a first pressure differential and to open at a second pressure differential which is different from the first pressure differential.

40. The system of claim 38 wherein the second level of suction is more negative than the first level of suction.

41. The system of claim 38 wherein the controller is configured to actuate the suction pump a the second level when tidal oscillations detected by the controller are diminished.

42. The system of claim 38 wherein the controller is configured to actuate the suction pump at the second level automatically on a periodic basis.

43. The system of claim 38 wherein the second level of suction is communicated to the tube relief lumen valve via the tribe drainage lumen to open the tube relief lumen valve.

44. The system of claim 38 wherein the tube comprises a chest tube defining, one or more drainage openings in fluid communication with the tube drainage lumen.

45. The system of claim 38 further comprising a drainage tube in fluid communication with the tube drainage lumen.

46. The system of claim 45 further comprising a fluid reservoir in fluid communication with the drainage tube.

47. The system of claim 45 further comprising a drainage tube relief lumen in fluid communication with the tube drainage lumen or the drainage tube.

48. The system of claim 47 further comprising a drainage tube relief lumen valve in fluid communication with the drainage tube relief lumen.

49. The system of claim 48 wherein the drainage tube relief lumen valve comprises a passively operated valve.

50. The system of claim 48 wherein the drainage tube relief lumen valve comprises an actively operated valve.

51. The system of claim 39 wherein the second pressure differential to open the tube relief lumen valve is greater than the first pressure differential to close the tube relief lumen valve.

52. The system of claim 38 wherein the tube relief lumen valve comprises a passively operated valve.

53. The system of claim 38 wherein the tube relief lumen valve comprises an actively operated valve.

54. The system of claim 38 wherein the tube relief lumen valve comprises a magnetic valve.

55. The system of claim 54 wherein the magnetic valve comprises a housing having a first element secured with the housing and a second element attached to a seal, wherein the seal has a first position in which a magnetic force between the first and second elements is greater than the first pressure differential and maintains the magnetic valve in a closed configuration, and wherein the seal has a second position in which the magnetic force is less than the second pressure differential and maintains the magnetic valve in an open configuration.

56. The system a claim 55 wherein one or both of the first and second elements comprises a magnet.

57. The system of claim 38 wherein the controller is configured to monitor a rate of air flow from the tube drainage lumen as an indicator of a thoracic air leak.

58. The system of claim 57 wherein the controller is configured to determine at least one parameter of the air leak.

59. The system of claim 57 further comprising a flow meter in communication with the controller.

60. The system of claim 57 wherein the controller is configured to monitor a number of revolutions of a vacuum pump in fluid communication with the tube drainage lumen.